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Recruiting Phase 2 NCT05672368

The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures

Phase 2 – studying effectiveness and dosage
Conditions: Disease or Disorder

Sponsor: City of Hope Medical Center

trial.available_in: БГ
Overview
This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port \[SP\]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.
Description
PRIMARY OBJECTIVE: I. To evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da Vinci SP1098) that is Food and Drug Administration (FDA)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures. OUTLINE: Patients undergo surgery using the da Vinci SP1098 robotic system on study.
Who can participate
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures * Age \> 18 years Exclusion Criteria: * Body mass index (BMI) \> 45 * Contraindications to minimally invasive surgery including chronic obstructive pulmonary disorders * Past history of failed attempt of minimally invasive abdominal or pelvic surgery
Interventions
Robot-Assisted Surgery
DEVICE
Locations 1
United States (1)
City of Hope Comprehensive Cancer Center
Duarte , California
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
26.04.2024
Completion date
13.10.2026
Registry ID
NCT05672368
Source
clinicaltrials.gov
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